EU approves Opdivo as adjuvant treatment for urothelial carcinoma
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression of at least 1% who are at a high risk of recurrence after undergoing radical resection.
With this EC decision, Opdivo becomes the first adjuvant immunotherapy option approved for patients in the European Union in this setting.
In the Phase III CheckMate -274 trial, Opdivo demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) compared to placebo in both all-randomized patients and in patients whose tumor cells express PD-L1 of at least 1%. The EC decision is based on the results in patients with tumor cell PD-L1 expression of at least 1%, which showed a 47% reduction in the risk of disease recurrence or death with Opdivo vs. placebo (Hazard Ratio [HR] 0.53; 95% Confidence Interval [CI]: 0.38 to 0.75; p=0.0005), with median DFS not reached with Opdivo compared to 8.41 months with placebo. Opdivo was generally well tolerated, with a safety profile that was consistent with previously reported Opdivo studies in patients with solid tumors.
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